WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE; NAIL, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Type
Injury
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Manufacturer Narrative
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510k: this report is for an unknown rafn spiral blade/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that the patient underwent a procedure on an unknown date, with retrograde approach for an ipsilateral hip/shaft at femoral shaft.Postoperatively, there was a union of fracture noted and patient had a missed femoral neck fracture, midshaft femoral fracture in which treated with rafn; displaced femoral neck fracture found one week later in which treated with open reduction internal fixation (orif) and doing well with healing of both fractures at follow up.There was an evidence of healing reported.No further information is available.This report is for an unknown rafn spiral blade.This is report 2 of 4 for (b)(4).
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Search Alerts/Recalls
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